I have a question that has caused much discussion here at work. When you have a test script that has expected results, can the actual results be typed? Does it have to be printed out and then signed? Or will only handwritten actual results be acceptable in a regulated (FDA) environment?

I have a question that has caused much discussion here at work. When you have a test script that has expected results, can the actual results be typed? Does it have to be printed out and then signed? Or will only handwritten actual results be acceptable in a regulated (FDA) environment?


They can be typed out, however, the raw (original data) needs to be maintained as well.

what's weird, is that I read somewhere on one of these threads (granted, it was from 2005) that it was ok to scan quality documents in -- but you had to retain the original as well. Our company has begun to eArchive all of our quality documents - destroying the originals once the scan has been verified. Our manufacturing sites are leary of this process....